Prospective Clinicogenomic Program

NCT04180176 | Completed Phase 4

• 1 other identifier: GX41563
• Study Type: interventional
• Target: 945
• Locations: 1 country
• Sites: 23

Brief Summary

The main purpose of this study is to evaluate the feasibility of a scalable, prospective research program for participants with metastatic non-small cell lung cancer (mNSCLC) or extensive-stage small-cell lung cancer (ES-SCLC) planning to start standard-of-care (SOC) systemic anti-cancer treatment. The study will also examine ctDNA status over the course of treatment as a predictor of response to therapy.

Conditions

Non-Small Cell Lung Cancer (NSCLC); Small-Cell Lung Cancer (SCLC)

Outcome Measures

Primary Outcomes (2)

• Proportion of Potential Eligible Participant Enrollment

  Up to 5 years

• Proportion of Enrolled Participants Submitting Sufficient Blood Samples

  At enrollment, then at pre-defined intervals from the first tumor assessment until disease assessment or end of therapy, whichever comes first, for up to 5 years.

Secondary Outcomes (1)

• Blood Level of ctDNA

  At enrollment, then at pre-defined intervals from the first tumor assessment until disease assessment or end of therapy, whichever comes first, for up to 5 years.

Study Arms (2)

All-Comer Cohort

EXPERIMENTAL

Participants with mNSCLC or ES-SCLC will give blood samples at three separate timepoints for ctDNA profiling.

Other: Blood Draw

Front-line Immunotherapy Re-enrollment Cohort

EXPERIMENTAL

Participants with mNSCLC or ES-SCLC that have received front-line treatment as defined by the protocol will give blood samples at three separate timepoints for ctDNA profiling.

Other: Blood Draw

Interventions

Blood Draw OTHER

Participants will have blood drawn at enrollment, the first tumor assessment, and at disease progression or end of therapy.

All-Comer Cohort; Front-line Immunotherapy Re-enrollment Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented diagnosis of mNSCLC or ES-SCLC
• Planned initiation of SOC systemic anti-cancer treatment
• Front-Line Immunotherapy Cohort: Received front-line treatment of an immune blockade therapy including anti-CTLA-4, anti-PD-1, or anti-PD-L1 therapeutic antibody on Protocol GX41563

You may not qualify if:

• \- Participant actively receiving investigational medicinal product(s) as part of an interventional trial at the time of signing informed consent

Sponsors & Collaborators

• Genentech, Inc.: lead
• Flatiron Health, Inc.; Foundation Medicine, Inc.: collaborator

Study Sites (23)

Alabama Oncology

Birmingham, Alabama, 35205, United States

Location

Clearview Cancer Institute

Huntsville, Alabama, 35805, United States

Location

Ironwood Cancer & Research Centers

Chandler, Arizona, 85224, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Florida Cancer Specialists; Department of Oncology

Fort Myers, Florida, 33901-8101, United States

Location

Florida Cancer Specialist, North Region

St. Petersburg, Florida, 33705, United States

Location

SCRI Florida Cancer Specialists PAN

Tallahassee, Florida, 32308, United States

Location

Florida Cancer Specialists

West Palm Beach, Florida, 33401, United States

Location

University Cancer & Blood Center, LLC; Research

Athens, Georgia, 30607, United States

Location

Piedmont Cancer Institute, PC

Atlanta, Georgia, 30318, United States

Location

Fort Wayne Med Oncology & Hematology Inc

Fort Wayne, Indiana, 46845, United States

Location

Cancer & Hematology Centers of Western Michigan

Grand Rapids, Michigan, 49503, United States

Location

Jackson Oncology Associates, PLLC

Jackson, Mississippi, 39202, United States

Location

Southeast Nebraska Cancer Ctr

Lincoln, Nebraska, 68510, United States

Location

Regional Cancer Care Associates LLC, Central Jersey Division

East Brunswick, New Jersey, 08816, United States

Location

Hematology Oncology Associates of Central New York

East Syracuse, New York, 13057, United States

Location

West Clinic

New York, New York, 10055, United States

Location

National Translational Research Group

Port Jefferson Station, New York, 11776, United States

Location

Oklahoma Cancer Specialists and Research Institute

Tulsa, Oklahoma, 74146, United States

Location

SCRI Tennessee Oncology Chattanooga

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Hematology Oncology Associates of Fredericksburg, Inc.

Fredericksburg, Virginia, 22408, United States

Location

Virginia Cancer Institute - Richmond

Richmond, Virginia, 23236, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 27, 2019
• Study Start: December 13, 2019
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

US (23)